- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05692843
Optimization of Cyclosporin in Atopic Dermatitis Through Multiomic Predictive Models of Treatment Response (DermAtOmics)
Optimization of Cyclosporin Therapy in Atopic Dermatitis Through Multiomic Predictive Models of Treatment Response (DermAtOmics)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Locations
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Madrid, Spain, 28046
- Recruiting
- Hospital La Paz
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Contact:
- Alberto M Borobia, MD, PhD
- Phone Number: MD, PhD
- Email: alberto.borobia@salud.madrid.org
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Cohort 1:
- Subjects diagnosed with moderate-severe atopic dermatitis who are going to receive treatment with cyclosporine.
- Participants must be willing and able to provide written informed consent prior the initiation of any study procedures.
- For children, parent/legal guardian must provide written informed consent. If age >11 years old, the minor must give assent.
- Participant is willing and able to adhere to the procedures specified in this protocol.
Cohort 2:
- Subjects diagnosed with moderate-severe atopic dermatitis who are receiving or have received in the past treatment with cyclosporine.
- Participants must be willing and able to provide written informed consent prior the initiation of any study procedures.
- For children, parent/legal guardian must provide written informed consent. If age >11 years old, the minor must give assent.
- Participant is willing and able to adhere to the procedures specified in this protocol.
Exclusion Criteria:
- Subjects participating in a clinical trial in the last three months.
- Any condition or situation precluding or interfering the compliance with the protocol.
- Women of childbearing potential must have a negative urine pregnancy test at Screening and Day 0.
- Women of childbearing potential must commit not to become pregnant. They must be willing to use highly effective contraceptive methods or have practiced sexual abstinence during the study. Highly effective contraceptive methods include oral, intravaginal, or transdermal combined (oestrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation; oral, injectable, or implantable progestogen-only hormonal contraception associated with inhibition of ovulation; intrauterine device; intrauterine hormone-releasing system; bilateral tubal occlusion; vasectomised partner and sexual abstinence.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Start of Cyclosporin treatment
Patients will receive the starting dose used in routine clinical practice (maximum dose of 3 mg/kg/day is standard practice in our center). Once the patient is included in the clinical trial their therapeutic management will be carried out according to usual clinical practice, but additional procedures will be performed:
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Once the patient is included in the clinical trial their therapeutic management will be carried out according to usual clinical practice, but additional procedures will be performed:
Other Names:
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Other: Receiving or received cyclosporin
If the patient is receiving cyclosporine therapy, a blood sample for pharmacogenetic analysis will be obtained at screening; also, at discretion of the treating physician, biological samples will be obtained (blood and urine) in this visit and in the follow-up visits to assess biochemical and kinetic variables. Clinical data (scales) will be collected from clinical records from treatment start until study inclusion and prospectively after study inclusion. If the patient received cyclosporine previously but is no longer under CsA therapy, a blood sample will be extracted at screening for pharmacogenetic analysis. Clinical data (scales) will be collected from clinical records. |
If the patient is receiving cyclosporine therapy, a blood sample for pharmacogenetic analysis will be obtained at screening; also, at discretion of the treating physician, biological samples will be obtained (blood and urine) in this visit and in the follow-up visits to assess biochemical and kinetic variables. Clinical data (scales) will be collected from clinical records from treatment start until study inclusion and prospectively after study inclusion. If the patient received cyclosporine previously but is no longer under CsA therapy, a blood sample will be extracted at screening for pharmacogenetic analysis. Clinical data (scales) will be collected from clinical records.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of patients with primary non-response to treatment with cyclosporine.
Time Frame: Week 16
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Fail to achieve EASI-75 (a 75% improvement in EASI score)
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Week 16
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of patients achieving EASI-75
Time Frame: week 6
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Fail to achieve EASI-75 (a 75% improvement in EASI score)
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week 6
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Percentage of patients reaching EASI-90
Time Frame: through study completion, an average of 1 year
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Percentage of patients reaching 90 percentage (EASI-90) improvement from baseline during follow-up
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through study completion, an average of 1 year
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Time to treatment failure after week 16
Time Frame: Week 24, week 32, week 40, week 48.
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Time to treatment failure with cyclosporine defined as EASI ≤ 50 during follow-up after week 16.
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Week 24, week 32, week 40, week 48.
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Mean percentage of change in EASI score
Time Frame: Week 16
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Mean percentage of change in EASI score from baseline to week 16
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Week 16
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Percentage of change in SCORAD
Time Frame: Week 16
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The Scoring of Atopic Dermatitis (SCORAD) is the score of the severity of atopic dermatitis.
It includes the evaluation of the affected areas.
The intensity of the lesions and the subjective symptoms of the patient.
Classifies AD as Mild >25, Moderate 25-50, and Severe >50
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Week 16
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improvement of at least 75% in SCORAD
Time Frame: through study completion, an average of 1 year
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Percentage of patients experiencing an improvement of at least 75% in SCORAD from the baseline value
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through study completion, an average of 1 year
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Change of IGA
Time Frame: week 16
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Investigator Global Assessment (IGA) is a simple objective measure providing an overall evaluation.
It uses a 5-point scale (clear=0; almost clear=1; mild=2; moderate=3; severe=4).
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week 16
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Time to IGA score of 0/1
Time Frame: through study completion, an average of 1 year
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Time to IGA score of 0/1 (clear or almost clear)
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through study completion, an average of 1 year
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Change of BSA
Time Frame: week 16
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Change of BSA (Body surface area) involment
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week 16
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Change in NRS
Time Frame: week 16
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NRS (Numerical Rating Scale) is a numerical scale that measures the intensity of pruritus, with 10 being the greatest intensity
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week 16
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Change in POEM
Time Frame: week 16
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The Patient-Oriented Eczema Measure (POEM) is a validated tool in which the patient self-assesses how many days they experienced seven distinct items (itch, sleep disturbance, bleeding, weeping/oozing, cracking, flaking, dryness of the skin) during a period of 1 week.
The maximum score is 28 points.
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week 16
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Change in DLQI
Time Frame: week 16
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Dermatology Life Quality Index is a validated and widely used 10-item questionnaire with paediatric versions (0-3 and 4-16 years).
A variation of 4 points is considered a clinically meaningful endpoint.
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week 16
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Percentage of patients having a variation of 4 points in their improvement in DLQI
Time Frame: through study completion, an average of 1 year
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Dermatology Life Quality Index is a validated and widely used 10-item questionnaire with paediatric versions (0-3 and 4-16 years).
A variation of 4 points is considered a clinically meaningful endpoint.
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through study completion, an average of 1 year
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Rate of adverse events associated to CsA treatment
Time Frame: through study completion, an average of 1 year
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Any untoward medical occurrence in a patient or clinical trial participant, which does not necessarily have a causal relationship with the research procedures or the investigational medicinal product
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through study completion, an average of 1 year
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Collaborators and Investigators
Investigators
- Principal Investigator: Alberto M Borobia, MD, PhD, Hospital La Paz
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Skin Diseases
- Immune System Diseases
- Hypersensitivity, Immediate
- Genetic Diseases, Inborn
- Skin Diseases, Genetic
- Hypersensitivity
- Skin Diseases, Eczematous
- Dermatitis
- Eczema
- Dermatitis, Atopic
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Enzyme Inhibitors
- Antirheumatic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Dermatologic Agents
- Antifungal Agents
- Calcineurin Inhibitors
- Cyclosporine
- Cyclosporins
Other Study ID Numbers
- 2022-500677-14-00
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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